San José, Costa Rica – October 18, 2016- Sanofi Pasteur, the vaccines global business unit of Sanofi, announced today that the Dengvaxia® dengue vaccine is now available in private healthcare clinics of Costa Rica for vaccination of individuals 9 to 45 years of age.
Dengue disease is endemic in Costa Rica with over 1.000 cases per 100.000 inhabitants reported in 2005 and 2013. Costa Rica had one of the highest incidence rates of dengue in all the American region in 2013. The country spends on average around USD$102 million each year on dengue, which includes costs for health care services during outbreak periods, vector control activities and medical indirect costs.2
“Having the dengue vaccine available in our country is an historical moment given the epidemiological situation we are facing and the need for new alternatives to dengue prevention that support the Integrated Management Strategy (IMS)”, affirmed Dra Maria Luisa Avila, Infectious Disease Peditrician, Hospital del Niño. “The impact of vector control efforts on dengue burden in Costa Rica has been limited, so having access to this new prevention tool against dengue is an important addition to our fight against this growing disease burden.
The burden of the disease in Costa Rica is considered high in most regions of the country. Since 2010 three serotypes are cocirculating (Denv-1, Denv-2 and Denv-3) and the oubreaks occur every two or three years. The most affected areas were Guancaste, Puntarenas, Alajuela and Limón, accounting for more than 85% of dengue cases in all the country.3 In an analysis made between 2005 and 2014, which includes an outbreak during 2013, hospitalizations were more frequent in people 10 to 29 years of age. The cost per an hospitalized case represents around $2.500 USD.
About Sanofi Pasteur Dengue Vaccine
Dengvaxia® dengue vaccine has received 11 marketing approvals to date: Mexico, The Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand, and Singapore. Regulatory review processes for Dengvaxia® are continuing in other countries where dengue is a public health priority.
Sanofi Pasteur’s vaccine is the culmination of over two decades of scientific innovation and collaboration, as well as 25 clinical studies in 15 countries around the world. Over 40,000 volunteers participated in the Sanofi Pasteur dengue vaccine clinical study program (phase I, II and III), of whom, 29,000 volunteers received the vaccine.
A summary of the efficacy documentation on Dengvaxia® for the study population 9 years and older population was published in The New England Journal of Medicine on July 27th 2015. These findings affirm the vaccine’s consistent efficacy in reducing dengue due to all four serotypes in two-thirds of the study participants 9 years and older and also documents the ability of the vaccine to prevent 8 out of 10 hospitalizations and up to 93% of severe dengue cases in this age group during the 25 month follow-up phase of the studies.4
An integrated safety analysis was recently published documenting Dengvaxia®’s satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In the study population 9 years and older, the results of this analysis documented that the vaccine protected against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination when compared to placebo.5
Sanofi Pasteur’s Dengue Vaccine is the first vaccine licensed for the prevention of dengue in the world. The vaccine is supplied from a dedicated production site in France.
Additional information about Sanofi Pasteur’s dengue vaccine is available on the web at www.dengue.info.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccines each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
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2 Xirinasht et al, Cost effectiveness analysis of Dengue Vaccine in Costa Rica, ISPOR Europe 2016.
3 Central American Countries Expert Board 2015 based on data fromCosta Rica MoH
4 Hadinegoro SR, et al. N Engl J Med 2015; 373:1195-206
5 Safety overview of a recombinant live-attenuated tetravalent dengue vaccine: pooled analysis of data from 18 clinical trials.Gailhardou et al PLoS Negl Trop Dis. 2016 Jul 14;10(7):e0004821. doi: 10.1371/journal.pntd.0004821